The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension

Cystoscopy procedure is performed on study Day 0 and study Day 14; no Investigational Product is inserted into the bladder.

Procedure: Sham

Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

Detailed Description:

The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Women age 18 and over

Diagnosed with Interstitial Cystitis as defined by protocol

Able and willing to complete questionnaires and diary

Able to comply with visit schedule including Day 14 Removal visit

Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

Pregnant or lactating women

Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product

History or presence of any condition that would make it difficult to evaluate symptoms

Did not complete blinded study (unblinded part of study only)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475253